The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn Care (ENC) curricula. These facilities are located within clusters in the Global Network for Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret, Kenya.

Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:

Perinatal Mortality [ Time Frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ] [ Designated as safety issue: No ]

The difference in the rate of perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among births ≥1500g, pre versus post implementation of an integrated package of HBB and ENC training and equipment (referred to as HBB/ENC training and equipment). This measure will be calculated using delivery data from the Global Network's Maternal Newborn Health Registry for participating clusters.

Secondary Outcome Measures:

Facility-based perinatal mortality [ Time Frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ] [ Designated as safety issue: No ]

The difference in the rate of facility-based perinatal mortality, among births ≥1500g pre versus post implementation of HBB/ENC training and equipment.

Asphyxia related perinatal mortality [ Time Frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ] [ Designated as safety issue: No ]

Health seeking behavior [ Time Frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ] [ Designated as safety issue: No ]

Facility deliveries [ Time Frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ] [ Designated as safety issue: No ]

The difference in the proportion of facility deliveries pre versus post HBB/ENC training.

Very early newborn death (within 1 day of birth) [ Time Frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ] [ Designated as safety issue: No ]

The difference in very early newborn death (within 1 day of birth) pre versus post HBB/ENC training.

Helping Babies Breathe (HBB) is a training program designed to resuscitate neonates regardless of where they were born. HBB was developed by the American Academy of Pediatrics (AAP), the NICHD's Global Network for Women's and Children's Health (GN), the Laerdal Foundation and their global partners. The HBB program was developed based upon the experience and results of an earlier Neonatal Resuscitation Program and the GN's FIRST BREATH randomized control trial.

The goal of the study is to test the impact of training birth attendants at selected health facilities in the Helping Babies Breathe (HBB) and Essential Newborn Care (ENC) curricula upon perinatal mortality (fresh stillbirths and early neonatal deaths), among births of ≥1500g. The training will take place in three GN sites, Kenya, and Nagpur and Belgaum, India. The study facilities serve the population in identified study clusters, defined geographic areas which participate in the GN's Maternal Newborn Health (MNH) Registry. In addition to measuring perinatal mortality rate pre and post training, the study will also assess resuscitation skills among the birth attendants as a result of the training. Quality Improvement activities are planned to ensure the integrity of the training, maintenance and availability of resuscitation equipment and skills maintenance.

The GN MNH Registry (NCT 01073475) was established in 2008 and includes all pregnancies and neonatal outcomes in defined geographic clusters. The primary outcome for the pre-post HBB evaluation study will be calculated using all delivery data from the GN MNH Registry for participating clusters during the defined study period.

The pre-post HBB evaluation will include the following key activities:

Selection of Master Trainers, Facilitators, and Learners

Country-level training of Master Trainers in the HBB and ENC curricula

Facility-level training of birth attendants in the HBB and ENC curricula

If a facility, master trainer, facilitator, or learner does not meet the above inclusion criteria they are excluded from the study.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01681017